Eligibility Module

Eligibility Module

The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.

Eligibility Module path is as follows:

Study -> Protocol Section -> Eligibility Module

Eligibility Module


Ignite Creation Date: 2025-12-24 @ 9:16 PM
Ignite Modification Date: 2025-12-24 @ 9:16 PM
NCT ID: NCT04122404
Eligibility Criteria: Inclusion Criteria: * HIV-positive * 18 years and above * Able to give informed consent * Admitted at the wards attached to the research site ART/HIV-clinic * Eligible for LF-LAM testing (defined by WHO in the LF-LAM policy update 2019): CD4-cell-count ≤200 cells/μL (the last measured CD4-cell-count); or a WHO clinical stage 3 or 4 event at presentation for care; or seriously ill defined by WHO (respiratory rate \> 30/min, temperature \> 39°C, heart rate \> 120/min or unable to walk unaided); or a positive WHO TB symptom screening including one of the following symptoms: current cough, fever, weight loss, or night sweats Exclusion Criteria: * Anti-tuberculous treatment including preventive treatment with Isoniazide within the last 60 days * Earlier participation in the same study
Healthy Volunteers: False
Sex: ALL
Minimum Age: 18 Years
Study: NCT04122404
Study Brief:
Protocol Section: NCT04122404